Colonic DiseasesNCT01570114
Covered Metallic Stent and Benign Colonic Strictures
An observational study of Colonic Diseases and Stricture, run by Société Française d'Endoscopie Digestive.
Trial summary
Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases, Stricture, Occlusion
- What is being tested?
- Fully covered metallic colonic stent
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in universitary tertiary care center benefited from a fully covered metallic colonic stent for treatment of benign stricture
Who may be able to join
- patients above 18 years of age
- symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy
Who cannot join
- Previous insertion or treatment of the stricture with metallic (covered or uncovered) stent
About this study
Official title: EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES
Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages over non-covered stents, including the possibility of retrieval and limited local tissue reaction, while providing alleviation of obstruction at possibly lower costs. Only few reports of fully covered metal stent placement in patients with benign colorectal strictures are available in the literature. The aim of this study was to assess the effectiveness of FCSEMS in the management of the colonic benign strictures.
Read the detailed description
It is a national multicentric retrospective study on the use of fully covered metal stent placement in patients with benign colorectal strictures.
Consecutive patients above 18 years of age with a symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy and which required the use of a FCSEMS were included. All strictures were confirmed to be benign by histology. All details concerning previous history, origins and treatment (medical or endoscopic) of the colonic stenosis were collected from the medical file.
Senior endoscopists with an experience of more than 50 colonic stent placements performed the procedure under general propofol-induced anesthesia with the same technic (The stent was placed under fluoroscopic and videoendoscopic controls).
Patients were required after the procedure to take oral osmotic laxatives regularly. Post-stenting complications were defined as immediate (during the procedure), early (occurring ≤ 30 days) and late (> 30 days) after the procedure. Stent removal and routine follow up endoscopy were scheduled 4 to 6 weeks after placement in most patients or earlier if complications occurred.
All patients were followed up at regular intervals based on their clinical situation. A retrospective chart review was performed to analyze the long-term outcome of the patients.
- Conditions
- Colonic Diseases, Stricture, Occlusion
- Being tested
- Fully covered metallic colonic stent
- Keywords
- Covered metallic stent, colon, benign stricture
- Medical subject headings
- Colonic Diseases, Constriction, Pathologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully covered metallic colonic stentDevice
Endoscopically insertion of fully covered metallic colonic stent
| Study group | Role | What they receive |
|---|---|---|
| covered metallic stent | Endoscopically insertion of fully covered metallic stent on benign colonic strictures Receives: Device: Fully covered metallic colonic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom resolution of colonic occlusion
Defined as the clinical (stools, stop pain) and radiological evidence of colonic decompression within 48 hours of stent insertion and without the need for reintervention
Measured: 48 hours
Secondary outcomes (4)
Successful stent placement
On the first attempt with complete deployment and precise positioning of the stent at the location of the stenosis, which was confirmed by fluoroscopy
Measured: Immediatly after stent insertion (one minute)
Successful stent retrieval
Possibility of retrieval the stent with a snare or a forceps
Measured: One minute (during colonoscopy for stent retrieval)
Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up
Perforation, bleeding, migration, pain, fecal incontinence and foreign body sensation, stent impaction and hyperplastic tissue overgrowth
Measured: 60 days
Recurrence of colonic occlusion
New episode of occlusion or subocclusion (pain with stool and gas discontinuation and imaging with cecum dilation) after stent retrieval or migration
Measured: 60 days, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
- Investigators
- Geoffroy Vanbiervliet, MD, Principal investigator, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570114
- Sponsor's protocol ID
- FCSEMS
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF A SELF EXPANDABLE FULLY COVERED METALLIC STENT IN THE TREATMENT OF BENIGN COLONIC STRICTURES
- ClinicalTrials.gov ID
- NCT01570114
- Acronym / sponsor ID
- FCSEMS
- Conditions
- Colonic Diseases, Stricture, Occlusion
- Keywords
- Covered metallic stent, colon, benign stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages over non-covered stents, including the possibility of retrieval and limited local tissue reaction, while providing alleviation of obstruction at possibly lower costs. Only few reports of fully covered metal stent placement in patients with benign colorectal strictures are available in the literature. The aim of this study was to assess the effectiveness of FCSEMS in the management of the colonic benign strictures.
Detailed description
It is a national multicentric retrospective study on the use of fully covered metal stent placement in patients with benign colorectal strictures.
Consecutive patients above 18 years of age with a symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy and which required the use of a FCSEMS were included. All strictures were confirmed to be benign by histology. All details concerning previous history, origins and treatment (medical or endoscopic) of the colonic stenosis were collected from the medical file.
Senior endoscopists with an experience of more than 50 colonic stent placements performed the procedure under general propofol-induced anesthesia with the same technic (The stent was placed under fluoroscopic and videoendoscopic controls).
Patients were required after the procedure to take oral osmotic laxatives regularly. Post-stenting complications were defined as immediate (during the procedure), early (occurring ≤ 30 days) and late (> 30 days) after the procedure. Stent removal and routine follow up endoscopy were scheduled 4 to 6 weeks after placement in most patients or earlier if complications occurred.
All patients were followed up at regular intervals based on their clinical situation. A retrospective chart review was performed to analyze the long-term outcome of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| covered metallic stent | – | Device: Fully covered metallic colonic stentEndoscopically insertion of fully covered metallic stent on benign colonic strictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in universitary tertiary care center benefited from a fully covered metallic colonic stent for treatment of benign stricture
Key inclusion criteria (2 listed)
- patients above 18 years of age
- symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy
Key exclusion criteria (1 listed)
- Previous insertion or treatment of the stricture with metallic (covered or uncovered) stent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully covered metallic colonic stentEndoscopically insertion of fully covered metallic colonic stent | Device | covered metallic stent |
Primary outcome
Symptom resolution of colonic occlusion
Time frame: 48 hours
Defined as the clinical (stools, stop pain) and radiological evidence of colonic decompression within 48 hours of stent insertion and without the need for reintervention
4 secondary outcomes
Successful stent placement
Time frame: Immediatly after stent insertion (one minute)
Successful stent retrieval
Time frame: One minute (during colonoscopy for stent retrieval)
Occurrence of any complication during interventional endoscopy, stent retrieval and the follow-up
Time frame: 60 days
Recurrence of colonic occlusion
Time frame: 60 days, 6 months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffroy Vanbiervliet, MD principal investigator
Société Française d'Endoscopie Digestive
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diseases and Stricture, run by Société Française d'Endoscopie Digestive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom resolution of colonic occlusion (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.